美国威尔康奈尔医学院Mario Gaudino团队研究了左后心包切开术预防心脏手术后心房颤动的效果。相关论文于2021年11月14日发表在《柳叶刀》杂志上。
心房颤动是心脏手术后最常见的并发症，与延长住院时间和增加不良结局（包括死亡和中风）有关。心包积液在心脏手术后很常见，可引发心房颤动。该研究验证了左后心包切开术（一种将心包腔引流至左胸膜腔的手术操作）可能降低心脏手术后心房颤动发生率的假设。
在这项适应性、随机、对照试验中，研究组招募年龄超过18岁的成年患者，均由美国纽约长老会医院威尔康奈尔医学院心胸外科的医师对冠状动脉、主动脉瓣或升主动脉进行选择性干预，或上述三者的组合。若患者没有房颤或其他心律失常史或实验干预禁忌症，则符合条件。
将符合条件的患者按1:1随机分配，按CHA2DS2-VASc评分进行分层，采用混合块随机方法，进行左后心包切开术或不进行干预。患者和评估人员对治疗任务不知情。患者随访至出院后30天。主要结局是术后住院期间房颤的发生率，在意向治疗（ITT）人群中进行评估。研究组对接受治疗的人群进行安全性评估。
2017年9月18日至2021年8月2日，研究组共筛查3601名患者，纳入420名患者，并将其随机分组，其中左后心包切开术组212例，非干预组208例。中位年龄为61.0岁，102名（24%）患者为女性，318名（76%）为男性，CHA2DS2-VASc评分中位数为2.0分。两组在临床和手术特征方面是平衡的。没有患者失去随访，数据完整性为100%。左后心包切开术组有3名患者未接受干预。
在ITT人群中，左后心包切开术组212例中有37例（17%）发生术后房颤，显著低于不干预组（208例中有66例[32%]）。左后心包切开术组209名患者中有2名（1%）在出院后30天内死亡，非干预组211名患者中有1名（1%）。左后心包切开术组209例中有26例（12%）术后发生心包积液，显著低于非干预组（211例中有45例[21%]），相对风险为0.58。左后心包切开术组有6例（3%）发生术后重大不良事件，非干预组有4例（2%）。未发现左后心包切开术相关并发症。
研究结果表明，左后心包切开术在降低冠状动脉、主动脉瓣或升主动脉手术后心房颤动的发生率方面非常有效，或可同时降低这些手术后并发症的风险。
附：英文原文
Title: Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial
Author: Mario Gaudino, Tommaso Sanna, Karla V Ballman, N Bryce Robinson, Irbaz Hameed, Katia Audisio, Mohamed Rahouma, Antonino Di Franco, Giovanni J Soletti, Christopher Lau, Lisa Q Rong, Massimo Massetti, Marc Gillinov, Niv Ad, Pierre Voisine, J Michael DiMaio, Joanna Chikwe, Stephen E Fremes, Filippo Crea, John D Puskas, Leonard Girardi
Issue&Volume: 2021-11-14
Abstract:
Background
Atrial fibrillation is the most common complication after cardiac surgery and is associated with extended in-hospital stay and increased adverse outcomes, including death and stroke. Pericardial effusion is common after cardiac surgery and can trigger atrial fibrillation. We tested the hypothesis that posterior left pericardiotomy, a surgical manoeuvre that drains the pericardial space into the left pleural cavity, might reduce the incidence of atrial fibrillation after cardiac surgery.
Methods
In this adaptive, randomised, controlled trial, we recruited adult patients (aged ≥18 years) undergoing elective interventions on the coronary arteries, aortic valve, or ascending aorta, or a combination of these, performed by members of the Department of Cardiothoracic Surgery from Weill Cornell Medicine at the New York Presbyterian Hospital in New York, NY, USA. Patients were eligible if they had no history of atrial fibrillation or other arrhythmias or contraindications to the experimental intervention. Eligible patients were randomly assigned (1:1), stratified by CHA2DS2-VASc score and using a mixed-block randomisation approach (block sizes of 4, 6, and 8), to posterior left pericardiotomy or no intervention. Patients and assessors were blinded to treatment assignment. Patients were followed up until 30 days after hospital discharge. The primary outcome was the incidence of atrial fibrillation during postoperative in-hospital stay, which was assessed in the intention-to-treat (ITT) population. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT02875405, and is now complete.
Findings
Between Sept 18, 2017, and Aug 2, 2021, 3601 patients were screened and 420 were included and randomly assigned to the posterior left pericardiotomy group (n=212) or the no intervention group (n=208; ITT population). The median age was 61·0 years (IQR 53·0–70·0), 102 (24%) patients were female, and 318 (76%) were male, with a median CHA2DS2-VASc score of 2·0 (IQR 1·0–3·0). The two groups were balanced with respect to clinical and surgical characteristics. No patients were lost to follow-up and data completeness was 100%. Three patients in the posterior left pericardiotomy group did not receive the intervention. In the ITT population, the incidence of postoperative atrial fibrillation was significantly lower in the posterior left pericardiotomy group than in the no intervention group (37 [17%] of 212 vs 66 [32%] of 208 [p=0·0007]; odds ratio adjusted for the stratification variable 0·44 [95% CI 0·27–0·70; p=0·0005]). Two (1%) of 209 patients in the posterior left pericardiotomy group and one (<1%) of 211 in the no intervention group died within 30 days after hospital discharge. The incidence of postoperative pericardial effusion was lower in the posterior left pericardiotomy group than in the no intervention group (26 [12%] of 209 vs 45 [21%] of 211; relative risk 0·58 [95% CI 0·37–0·91]). Postoperative major adverse events occurred in six (3%) patients in the posterior left pericardiotomy group and in four (2%) in the no intervention group. No posterior left pericardiotomy related complications were seen.
Interpretation
Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, aortic valve, or ascending aorta, or a combination of these without additional risk of postoperative complications.
DOI: 10.1016/S0140-6736(21)02490-9
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02490-9/fulltext
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